Skip to content
CompletedPhase 1 / Phase 2Results posted

Ketamine + Mindfulness for Depression

NCT05168735 · Rebecca Price

Closed to entry
Status
Not accepting participants
Phase 1 / Phase 2
Phase
43
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

In this project, the investigators will administer a single infusion of IV ketamine to depressed patients and randomize the patients to receive either a) usual/typical infusion conditions or b) mindfulness training and exercises in conjunction with the infusion. Investigators will test whether the conjunction of ketamine + mindfulness enhances the reductions in depression following a single ketamine infusion.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Montgomery-Asberg Depression Rating Scale

    Measured over 24hrs post-intervention

  • Montgomery-Asberg Depression Rating Scale

    Measured over 5 days post-intervention

  • Montgomery-Asberg Depression Rating Scale

    Measured over 12 days post-intervention

  • Montgomery-Asberg Depression Rating Scale

    Measured over 21 days post-intervention

  • Montgomery-Asberg Depression Rating Scale

    Measured over 30 days post-intervention

  • State Mindfulness Scale

    Measured over 80min post-infusion

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: All participants will: 1. be between the ages of 18 and 65 years, 2. score ≥ 14 on the Hamilton Depression Rating Scale (modified Ham-D) 3. possess a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document Exclusion Criteria: All participants: 1. Presence of lifetime bipolar, psychotic, or autism spectrum; current problematic substance use (e.g., ongoing moderate-to-severe substance use disorder); 2. Acute suicidality or other psychiatric crises requiring treatment escalation. We will use the Columbia Suicide Severity Rating Scale (CSSRS) as both an initial exclusion criteria (CSSRS "Baseline/Screening" Version for past 1month period) and as grounds for rescue/removal (CSSRS "Since Last Visit" form). The CSSRS will be administered using a paper form by an experienced and thoroughly trained clinical assessor on the study team. Subjects with CSSRS suicide ideation scores scored "yes" on items 4 (active suicidal ideation with some intent to act) and/or 5 (active suicidal ideation with specific plan and intent) will be excluded from the study, and if enrolled, will be exited from the study and referred immediately to the nearest emergency mental health facility for additional thorough assessment and appropriate treatment referral. 3. Changes made to treatment regimen within 4 weeks of baseline assessment. 4. Reading level \<6th grade as per patient self-report. 5. Patients who have received ECT in the past 2 months prior to Screening. 6. Current pregnancy or breastfeeding 7. Patients must be reasonable medical candidates for ketamine infusion, as determined by a physician co-investigator. Serious, unstable medical illnesses including respiratory \[obstructive sleep apnea, or history of difficulty with airway management during previous anesthetics\], cardiovascular \[including ischemic heart disease and uncontrolled hypertension\], and neurologic \[including history of severe head injury\] will be exclusions. 8. Clinically significant abnormal findings of laboratory parameters \[including urine toxicology screen for unreported drugs of abuse\], vitals, or ECG. 9. Uncontrolled or poorly controlled hypertension, as determined by a physician co-investigator's review of vitals collected during screening and any other relevant medical history/records. 10. Patients with one or more seizures without a clear and resolved etiology. 11. Patients starting hormonal treatment (e.g., estrogen) in the 3 months prior to Screening. 12. Past intolerance or hypersensitivity to ketamine. 13. Patients taking medications with known activity at the NMDA or AMPA glutamate receptor \[riluzole, amantadine, memantine, topiramate, dextromethorphan, D-cycloserine\], or the mu-opioid receptor \[opiate medications--morphine, oxycodone, heroin, fentanyl)\]. However, lamotrigine will not be a study exclusion given that it has been shown not to impact ketamine's safety profile or its antidepressant efficacy. 14. Patients taking any of the following medications: St John's Wort, theophylline, tramadol, metrizamide. 15. Patients who report meditating with mindfulness techniques \>1 hour weekly (on average) for the past 6 months or longer.

Where

1 study site

FacilityCityRegionCountry
Western Psychiatric Institute and ClinicPittsburghPennsylvaniaUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05168735 on ClinicalTrials.gov →

Last updated in the registry 2024-08-20. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits